Director, Global Regulatory Affairs

Cardinal Health

16d

About The Position

The Director of Global Regulatory Affairs leads a global team of 50 regulatory experts and consultants responsible for regulatory strategy, regulatory submissions, and regulatory agency engagement. This role drives successful regulatory outcomes and plays a key role in developing talent across a distributed team of consultants. This position reports to the Vice President, Biopharma Regulatory Affairs

Requirements

15+ years of pharmaceutical industry experience, including 10+ in regulatory affairs preferred
Bachelor’s degree preferred; MS, PharmD, or PhD preferred
Experience in a consulting environment
Strong business acumen and team leadership skills, developing and growing a consulting team
Deep technical knowledge of regulatory requirements (FDA, EMA, ICH, GLP, GMP, GCP)
Strong written, verbal, and cross-functional communication skills
Proven ability to lead and develop teams, especially consulting or matrixed environments
Ability to travel up to 25%
Strategic and enterprise-minded leader with a collaborative style.
Strong mentor committed to developing early-career and established consultants.
Creative, ethical, and decisive communicator with strong executive presence.

Responsibilities

Regulatory Strategy & Leadership Develop and execute global regulatory strategies across diverse product portfolios. Provide expert leadership to internal teams and clients, ensuring regulatory excellence.
Regulatory Submissions & Compliance Direct preparation and management of IND, NDA, and global regulatory submissions. Support clinical study design, data analysis, and compliance with FDA, EMA, and ICH requirements.
Training, Mentorship, & Development of Consultants Serve as a hands-on leader committed to developing regulatory consultants at all experience levels. Create structured training, onboarding, and professional development programs for consultants. Provide routine coaching, mentorship, and skills development aligned with individual growth trajectories. Foster a learning culture that emphasizes technical expertise, regulatory judgment, and career mobility. Ensure junior and mid-level consultants gain exposure to complex projects and cross-functional teams.
External Agency Engagement Build and sustain productive relationships with U.S. and global regulatory authorities. Act as spokesperson on significant regulatory matters and strengthen agency dialogue.
Business Leadership & Growth Partner with executive leadership to drive business strategy and long-term growth. Provide financial oversight including project budgeting and resource allocation.

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs